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NCT07727824
Endoscopic Treatment
Conditions: Stenoses, Dyspnea
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 96
Sponsor: University Hospital, Toulouse
Location: Hôpital Marie Lannelongue / Institut Gustave Roussy Le Plessis-Robinson
Summary
The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the patient's anatomy. The main consequences of this lack of congruity are stent migration and granulomatous inflammatory reactions. The investigators hypothesized that personalized endoprostheses could significantly reduce the complication rate and improve tolerability. In this randomized controlled trial, the investigators propose to evaluate whether personalized endoprostheses allow for better management of non-malignant central airway stenoses by comparing this new approach to standard care.
Eligibility Criteria
Inclusion Criteria:
* Age \>18 years,
* Central non-malignant symptomatic (dyspnea \> grade 2 mMRC or post-stenotic infection) airway stenosis with silicone stent implantation indication (viable downstream airways, pulmonary artery and parenchyma),
* To have access to a personal telephone for the teleconsultation scheduled in the protocol,
* Informed consent signed,
* Health insurance beneficiary.
Exclusion Criteria:
* Acute respiratory distress,
* Mechanical ventilation,
* Contraindication to rigid bronchoscopy: severe coagulation disorders that cannot be corrected, anticoagulant or antiplatelet therapy other than aspirin within 5 days prior to the stent implantation,
* Malignant stenosis,
* Pregnancy or breast-feeding,
* A situation in which emergency or semi-emergency intervention (less than 48 hours) may be anticipated (like an acute respiratory distress for example),
* Patient under legal protection, - Participation in another study with an exclusion period still in progress,
* Impossibility of giving the person informed information and of ensuring the subject's compliance due to impaired physical and/or psychological health.
Source: ClinicalTrials.gov (NCT07727824). StuddyBuddy aggregates publicly available trial information.